| Primary Device ID | 10871321001956 |
| NIH Device Record Key | 760ac625-8a5e-4b59-9bed-7039c9d1d5b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Labtician Oval Sleeve™ |
| Version Model Number | S 3084 |
| Company DUNS | 248911026 |
| Company Name | Labtician Ophthalmics, Inc |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00871321000815 [Unit of Use] |
| GS1 | 10871321001956 [Primary] |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2015-10-09 |
| 18713210001956 | S 3084 |
| 18713210001949 | S 3083 |
| 10871321001956 | S 3084 |
| 10871321001949 | S 3083 |